1. Field of the Invention
This invention relates to an improved device and process for preventing cross-spike or improper substitution or intermixing of critically distinct fluids utilized in connection with a plasmapheresis or blood donor/collection apparatus.
2. Background Information
Typical of the prior art references regarding plasmapheresis and blood donor or collection apparatus or processes are U.S. Pat. Nos. 4,976,851; 4,954,128; 4,043,501; Des. 305,506; 5,173,257; 5,171,432; 5,171,430; 5,153,828; 5,149,501; 5,143,602; 5,046,608; 5,037,549; 5,011,705; 4,994,022; 4,994,021; 4,990,132; 4,975,186; 4,967,763; 4,940,543; 4,790,330; 4,568,345; 4,044,983; Des. 334,536 and Des. 335,450; which were located during the process of a patent search. Copies or Patent Gazette reference copies of all patents cited were enclosed with the filed application in this matter, pursuant to 37 C.F.R., sections 1.97-1.99.
U.S. Pat. No. 4,043,501; issued to Larrabee et al., discloses a portable liquid package container for use with a blood washing device, in providing a portable liquid package container arrangement in connective bin-type slots for supplying saline solutions and recovery of washed blood and waste liquid, essentially claiming a linearly oriented, vertically partitioned support area for receiving some five or so collapseable containers for apparent separation and use in the blood washing device. As disclosed and claimed, Larrabee is considerably different in structure and function form the present invention, and would appear by virtue thereof to lend itself to problems of intermixing or substituting improper containers in respective slots.
U.S. Pat. No. 4,976,851; issued to Tanokura et al., disclosing a liquid separator for use as a blood component separator functions to separate a blood component such as blood plasma from centrifugally separated component layers in a flexible blood bag.
U.S. Pat. No. 4,954,128; issued to Ford, discloses a plasmapheresis instrument and a harness set to be utilized therewith. During the infusion cycle, or cycle in which fluids are provided to a respective donor, which alternates with the collection cycle of the Ford device, the blood constituent from the reservoir and a replacement fluid are mixed externally of a reservoir and pumped to the donor. An anticoagulent supply container 44 in Ford, and a replacement fluid supply container 46 therein are essentially provided overhead of the device and oriented in position and relation to the Ford device and its tubing components such that a substantial risk exists for intermixing, improper substitution or cross-spiking of anticoagulent and replacement fluid which during the plasmapheresis process could cause severe damage or death to a respective blood or plasma donor.
Additionally, some designs for plasma containers, bottles or the like have been patented such as the above referenced '506 Sittig, '536 Long et al. and the '450 Pezzoli et al. design patent references; but each is substantially different in design from the present invention.
None of the references specifically illustrates the present invention. Nor is the present invention obvious in view of any of the prior art references listed herein. In addition, all of the relevant prior art heretofore known suffer from a number of disadvantages.
(a) The prior art devices do not provide substantially adequate means of preventing against the cross-spiking or cross-connecting of one of several critical fluid lines which may be a part of or necessary in an electrophoresis, plasmaphoresis or blood collection process, such as connection lines from saline solution and anticoagulant fluid.
(b) The prior art devices substantially run the risk of the potentially fatal cross-spiking or cross connecting of anticoagulent fluid and saline solution, where these fluids are incorrectly and improperly provided respectively to a plasma or blood collection device, or device for plasmapheresis, and administered to a plasma or blood donor, causing serious problems for the donor, cell damage or loss to blood already circulating in the plasmapheresis device, or health problems related to the rapid infusion in the donor of anticoagulant fluid.
(c) It is a further disadvantage of the prior art that required fluids which must be kept separated and utilized in the process of collecting plasma or blood at the right time and location are often provided in linear arrangement, one adjoining the other in position, such that improper storing separation and categorization for proper utilization and safety is frequently subject to occur, resulting in the wrong type of fluid communication lines being connected to an otherwise properly installed fluid container; in each event causing cross-spiking or cross connecting and supply of these critical respective fluids.
(d) Additionally, the prior art devices have not advantageously utilized the size of fluid containers, the length of respective fluid supply lines, proper line guiding means and the spatial location and installation of fluid retaining and holding devices to substantially protect against the danger of cross-spiking of critical, independent fluids.
(e) A further disadvantage of the prior art has been that some of the prior art devices or systems provide placement of necessary critical fluids in positions separate from or not integrally related to the central plasmapheresis or blood collection device.
These and other disadvantages of the prior art will become apparent in reviewing the remainder of the present specification and the drawings.
Accordingly, it is an object of the present invention to provide a substantially improved means of assuring separation of important or necessary, respective process and replacement fluids utilized in the operation of a plasma or blood donation-collection device.
It is a further object of the invention to provide a cross-spike prevention system which will substantially prevent cross-mixing of potentially dangerous fluids, physical damage to a respective donor and damage or loss of respective blood cells or materials already in a device for collecting plasma or blood.
It is yet a further object of the present invention to provide a device and system for prevention of cross-spiking or cross-mixing of otherwise potentially dangerous, critical required infusion and collection fluids, which takes advantage of spatial installation and location, tube communication line length and orientation, and strategically placed guide means such that a respective fluid can be properly placed and connected in a cross-spike prevention receptacle which is properly dimensioned to receive only a container of this respective fluid, and which can be attached in a user-friendly manner to a number of plasma and blood collection units as an attached or integral part of a given such unit.
And it is a further object of the present invention to provide a device and system which will improve and make more safe the function and process of many different types of already existing plasmapheresis and blood collection and donor assemblies and apparatus, by improving each respective unit's ability to isolate important fluids to be utilized in a given collection process such that each respective fluid can be utilized in the proper sequence or time to allow the respective device to function properly in preserving collected blood materials and in preventing the infusion of dangerous fluids into a given subject donor.